510(k) Report

Devices descending from K050809

870 later devices reach CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K171881JAZZ Passer BandImplanet, S.A.20170—
+6K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+6K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+6K170647Connector SystemOrthofix, Inc.201718—
+6K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+6K162575Z-LINKPC SystemZavation, LLC20173—
+6K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+6K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+6K150918PASS OCT Spinal SystemMedicrea International SA201513—
+6K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+6K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+6K141284Caspian Spinal SystemK2m, Inc.20140—
+6K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+6K131833Centurion Poct SystemOrthofix, Inc.20142—
+6K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+6K120998Solstice Cross ConnectorLife Spine20121—
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+7K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+7K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+7K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+7K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+7K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+7K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+7K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+7K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+7K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+7K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+7K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+7K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+7K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+7K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+7K242042TriALTIS™ Spine SystemMedos International SARL20241—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K233256Robotic Integration InstrumentsDePuy Synthes20240—
+7K240368E3D™-A Interbody SystemEvolution Spine20247—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K240526POWEReam Xia/SerratoStryker Instruments20240—
+7K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+7K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+7K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+7K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+7K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+7K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+7K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+7K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+7K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+7K230989Rod Registration FrameNu Vasive, Incorporated20230—
+7K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+7K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+7K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+7K222789VADER® Pedicle System, G21 CementIcotec AG202352
+7K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+7K223294SpineJack® Expansion KitStryker Instruments20221—
+7K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+7K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+7K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+7K222698CUVIS-spineCurexo, Inc.20220—
+7K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+7K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+7K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+7K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+7K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+7K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+7K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+7K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+7K201585Monterey AL Interbody SystemStryker Corporation202044
+7K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+7K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+7K193129Yukon OCT Spinal SystemK2m, Inc.202001
+7K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+7K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+7K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+7K182470Plateau Spacer SystemLife Spine20180—
+7K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+7K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+7K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+7K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+7K172194Connector SystemOrthofix, Inc.2017162
+7K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+7K161149PASS OCT Spinal SystemMedicrea International SA20160—
+7K160756PASS OCT Spinal SystemMedicrea International SA20160—
+7K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+7K153169PASS OCT Patient Specific RodsMedicrea International20164—
+7K152211PCT SystemCentinel Spine, Inc.20150—
+7K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+7K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+8K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+8K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—